Single and Multiple-Ascending Dose Study of CRN04894 in Healthy Volunteers

• Sponsor: Crinetics Pharmaceuticals Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT06048887
• Collaborator: (none)
• Enrollment: 88
• Location: 1
• Arms: 2
• Actual Duration (Months): 15.7
• Patients Per Site Per Month: 5.6

Study Details

Study Description

Brief Summary

A Phase 1, first-in-human, double-blind, randomized, placebo-controlled study to evaluate the safety of CRN04894 in healthy volunteers as well as the relationship between exposure and pharmacodynamic (PD) parameters.

Condition or Disease	Intervention/Treatment	Phase
Healthy Volunteers	Drug: CRN04894 Oral Solution; Drug: Placebo Oral Solution	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 88 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Double-blind, Randomized, Placebo-controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of CRN04894 in Healthy Volunteers
• Actual Study Start Date: Dec 18, 2020
• Actual Primary Completion Date: Apr 11, 2022
• Actual Study Completion Date: Apr 11, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Single Ascending Dose (Part 1)	Drug: CRN04894 Oral Solution; CRN04894 is an orally active nonpeptide melanocortin 2 receptor (MC2R) or adrenocorticotropic hormone (ACTH) antagonist.; Drug: Placebo Oral Solution; Placebo
Experimental: Multiple Ascending Dose (Part 2)	Drug: CRN04894 Oral Solution; CRN04894 is an orally active nonpeptide melanocortin 2 receptor (MC2R) or adrenocorticotropic hormone (ACTH) antagonist.; Drug: Placebo Oral Solution; Placebo

Outcome Measures

Primary Outcome Measures

1. Percentage of subjects with treatment-emergent adverse events [Part 1 - up to Day 8; Part 2 - up to Day 20]

2. Proportion of participants with a clinically significant safety laboratory observation [Part 1 - up to Day 8; Part 2 - up to Day 20]

Secondary Outcome Measures

1. Pharmacokinetics (AUC) [Part 1 - up to Day 8; Part 2 - up to Day 20]

   Assessment of the plasma area under the curve of CRN04894

2. Pharmacokinetics (Cmax) [Part 1 - up to Day 8; Part 2 - up to Day 20]

   Assessment of the maximum observed plasma concentration of CRN04894

3. Pharmacokinetics (Tmax) [Part 1 - up to Day 8; Part 2 - up to Day 20]

   Assessment of time to maximal CRN04894 concentration (Tmax)

4. Pharmacokinetics (T1/2) [Part 1 - up to Day 8; Part 2 - up to Day 20]

   Assessment of elimination half-life of CRN04894

Other Outcome Measures

1. Change in ACTH-stimulated serum cortisol [Part 1 - Day 1; Part 2 - Day 10]

2. Change in serum cortisol [Part 1 - up to Day 8; Part 2 - up to Day 20]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Females must be either postmenopausal or surgically sterile; or using stable and permitted highly effective method of contraception - use of oral hormonal contraceptives are not allowed during the study

• Male subjects must be surgically sterile or agree to use highly effective form of contraception when sexually active with a female partner of child bearing potential

• ACTH-stimulated serum cortisol high-dose ACTH stimulation test conducted at Screening

Exclusion Criteria:

• Use of topical, nasal, inhaled, or oral corticosteroids.

• Use of any investigational drug within the past 60 days.

• Have a medically significant illness within 30 days prior to screening.

• Use of prohibited prescribed or nonprescribed medications and/or nonmedications/alternative medicinal products.

• Any condition that in the opinion of the investigator would jeopardize the subject's appropriate participation in this study.

• Unstable psychological disorder ≤1 year prior to Screening.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	QPS-Miami Research Associates	Miami	Florida	United States	33143

Sponsors and Collaborators

• Crinetics Pharmaceuticals Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Crinetics Pharmaceuticals Inc.
• ClinicalTrials.gov Identifier: NCT06048887
• Other Study ID Numbers: CRN04894-01
• First Posted: Sep 21, 2023
• Last Update Posted: Sep 21, 2023
• Last Verified: Sep 1, 2023

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Pharmaceutical Solutions

Study Results

No Results Posted as of Sep 21, 2023